Today the FDA external advisory committee, called VRBPAC, met to discuss and vote on the safety and effectiveness of two COVID19 vaccines (Moderna and Pfizer) for under 5 year olds.
I have been vaccinated and boosted. I most enjoy the MRNA technology. I read through each of the data sets and graphs - including higher rates of hospitialization. I have not seen a clean statement of reduced risk, more importantly a projection of reduced risk giving children a vaccine designed to protect against an older version of COVID. The antibody activity is fine, we know the key for adults is now the impact on T and B cells of the immune system. Everyone fails to acknowledge the lack of longitudinal data and for low probability events - they will not show in small clinical trials. The vaccines for children may work great - the data available is limited. This should be made clear up front. We are going to give vaccines for old variants of covid - we dont' give children vaccines for old variants of the flu
As a mom, I whole-heartedly agree with the statement. We don't do flu shots as a family unless there's a reason - such as I have a newborn at home who has a weaker immune system. Why?
1. It's a vaccine that's required every single year (vs 2-3 shots and done / protected for life)
2. The flu virus mutates quick enough that it's a bit of a guessing game with the vaccine what the dominant variant will be in that flu season.
3. The risk is relatively low if my child catches the flu.
I'm vaccinated and boosted against COVID but, with all the new data coming out, it seems like our current vaccines are not a long term strategy. I also think the data that the CDC put out on efficacy over time with the 5-11 year old vaccine proves that we really don't have enough data with lower doses to show it's effective beyond a very short window of time. I'm not convinced that micro-dosing out in the wild isn't as effective or close to as effective as the vaccine, over time, for younger ages - but that approach has limited research funding since there's no one to fund it.
Keep in mind that an important reason to vaccinate against the flu is to reduce spread to those who are more vulnerable (older people, children who are too young to be vaccinated, people with immune disorders, people undergoing cancer treatments, and people with certain organ disorders).
Far too many people die from the flu every year (roughly 30,000-80,000 in the U.S. most years). We could reduce those numbers a lot if more of us who can be vaccinated do so annually.
Yes. In a perfect world where you know the dominant strain for that year and the vaccine is made for that strain this is correct. While I respect peoples decision to get the flu shot, it’s not a herd immunity vaccine and it doesn’t meet my personal threshold in most years. It’s also not a required vaccine so, to some extent, it doesn’t meet the medical communities threshold for required vaccination either.
I had never heard the phrase “not a herd immunity vaccine,” although I understood your meaning. Of course, that’s because the virus mutates so much, so it’s challenging to come up with such a thing.
But in the process I came across this, which notes two relevant things:
(1) a vaccine that works against all mutations of the flu virus, current and future, is in development.
But also (2) the flu vaccines we have now would be more effective if more people got vaccinated, because otherwise we get more mutations.
“It would sure help if more people GOT their flu vaccine though… we only get about half of people covered in the United States each year. And every new case is another chance for the virus to mutate. Really high vaccine coverage could slow down the drift process and make this year’s vaccine last longer.”
Even in a not perfect world, it will slow spread if it’s at all effective. Slowing spread a little can add up to big numbers, as we all have seen recently.
Yes, your choice, of course. But there’s a reason public health scientists recommend them: to save lives.
And also, of course, to reduce unnecessary suffering and long-term effects for those who catch and survive the flu. It’s not nothing.
I thought the flu was no big deal until I caught it 10 years ago. Turns out I was thinking of what people call the “stomach flu,” which isn’t a flu at all. The actual flu was a miserable experience I would rather not go through again, at a healthy, fit 44 years old. I’d never want to put a kid through that, or an elderly person.
Having closely followed the roll out here in Australia, I don't feel reassured by your words. Here's a short clip of a very nervous Queensland Chief Health Officer Dr John Gerrard telling us they're "keeping a close eye" on reports of people dying suddenly from myocarditis after a short illness: https://rumble.com/vwhgw9-australian-health-official-vaxed-are-dying-from-myocarditis.html
Note how he corrects himself from "a few" reports to "reports". Months before this press conference, it was reported in our media that two Australian journalists were hospitalised for myocarditis following pfizer (Georgia Clark and Denham Hitchock). Denham Hitchock's case certainly wasn't mild and we don't know if there's permanent scarring that could increase his risk of chronic heart failure in the future.
A couple of reporters shout out, asking if it's the vaccines but D'Ath dismisses them, saying "Vaccines actually help people stay out of hospital".
Here are testimonials from ICU nurses (general and cardiac) at a Health and Welfare Meeting of the Louisiana House of Reps about the "terrifying" injuries they're seeing from these shots. The nurses all say the injuries are not being reported to VAERS. They speak at the one hour mark: https://house.louisiana.gov/H_Video/VideoArchivePlayer?v=house/2021/nov/1108_21_HW
In this climate of fierce censorship, you'll get a better idea of what's going on by physically going to places yourself or ringing people up and speaking to them directly. You can contact Monte Vista school in CAL; they have 4 cases of myocarditis following the shots in approx 800 students (presumably 50% boys.)
The rate at Monte Vista fits what I've seen in this city of Melbourne, Australia. I don't know that many people but I know two young men (aged 20) who are friends who both got myocarditis after pfizer. They're being seen by the same cardiologist. Neither case is mild. Their prognosis is unknown.
Despite the censorship, you can still find studies that report a higher incidence of myocarditis from the Covid shots. When the study by Patone et al. was redone according to age and gender, investigators found a higher rate of myocarditis in jab recipients skewed to younger males.
As for heart inflammation from the mRNA shots being mild and rare, Ernest Ramirez's son Ernesto aged 16 died after pfizer. Mr. Ramirez didn't know there was any risk of death. He was offered money to keep quiet but refused. There are other cases such as that of Sean Hartman.
Published studies have found permanent damage to hearts following the mRNA shots in the form of fibrosis (Bozkurt et al) and necrosis (Matta et al.), so it's reasonable to think that in some cases extensive damage could lead to death.
You recommend Moderna over Pfizer. We know males of younger age are more at risk of heart inflammation from the mRNA shots and there's a higher risk with Moderna (Sweden, Norway and Finland halted Moderna in under 30s). I therefore don't understand your logic that myocarditis could be less common in the youngest age group, particularly when you're advocating Moderna.
We know the trials in adults were under powered to detect myocarditis but that it still occurred in the real world. There are over 1000 peer-reviewed papers on other adverse effects from the Covid shots, such as transverse myelitis that appeared on FDA slides in December 2020 and is listed in pfizer's postmarketing experience document.
Even without extensive real world data on injuries, there were major red flags in the original RCTs:
Compare the NEJM report with the FDA one on the Pfizer trial for ages 12-15. Do you know the reasons for the discrepancy in numbers of children who didn't receive a second dose? Do you know the reasons why these children didn't get a second dose?
Brianne Dressen's severe neurological AE was censored from the AZ trial because it occurred after one dose. There's every reason to suspect that could have gone on in the Pfizer trial. Moreover, both Brianne and Stephanie de Garay (whose daughter Maddie was paralysed on the pfizer trial) say trial participants could only report AEs by choosing from a pre-specified list of minor ones.
I question the reliability of any source that makes statements I consider disingenuous. You said Pfizer reporting scalding from coffee (nothing to do with their drug) was an example of rigour. You neglect to mention they passed off a case of paralysis in a child aged twelve as a stomach ache in their published report. It's blatant fraud and criminally negligent not to investigate such a severe case before rolling out to healthy children.
You're strongly urging parents to give their babies and toddlers what the FDA in 2020 considered to be experimental (the EUA document calls the Covid vaccines "investigational") gene therapy (Moderna's SEC filing document from April 2020 states the FDA considered mRNA to be gene therapy.)
If a product is marketed as a vaccine, then certain safety studies don't need to be done; studies in carcinogenicity and genotoxicity were not done because the drug was not "expected' to have an adverse effect in this regard, as you can see on page 29 of Pfizer's document:https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_24_nonclinical-overview.pdf
Clinical trials to determine safety in reproductive health are ongoing. You may be aware that menstrual irregularities have been reported globally, including in the BMJ. There are two reports of vaginal haemorrhaging in a woman and a child aged 11 on the TGA DAEN website. The child appears on page 35. Note the rat bleeding on the vulva that was euthanized (page 55) in the pfizer study:
Note also how much of this animal study in safety is redacted. As a parent, does any of this concern you?
The covid inoculations don't reduce transmission at all. The only reason to give these mRNA drugs to children would be to reduce their risk of a severe outcome. Where's the evidence, even in the original clinical trials in adults for the original variant, that they reduce the risk of a severe outcome?
These drugs are, at best, a symptom mitigator with a limited window of efficacy.
I'm happy for all those families with little ones who have waited so long. Congratulations :)
Vaccination, even against the original coronavirus, seems to be holding up as our best option against new variants, long Covid, reinfection, and longer term bad stuff that gets discussed by thought leaders on sites like twitter.
I will definitely be recommending vaccination with the existing mRNA vaccines for this age group as an imperfect, better-late-than-never imperative. Thanks for the unofficial tilt towards Moderna over Pfizer in the <5 yo's.
Anticipating a bivalent (including Omicron) booster in the fall for adults and kids most likely, and I'm tilting towards mixing and matching boosters.
I'm not sure we'll see the efficacy of an omicron-included booster (but I hope I'm wrong). I'm holding out for a pan-sarbovirus vaccine within a couple of years, though. Agree with your comments overall. I'll be recommending vaccination for the kids, and I've already started preferring a mix'n'match approach on the third (completion) done and booster.
First things first: I suspect the immunity derived from breastfeeding has an IgA component. Thus, a better mucosal response for those who got a load of antibodies that way. Studies looking, in vitro, at IgA effect on on SARS-CoV-2 noted that mucosal response was more likely to reduce viral load and prevent at least symptomatic disease.
I've been in the Hotez camp for a long time: If the first 2 doses of mRNA vaccines had been 10-12 weeks apart, the 3rd dose might not be necessary (but that remains speculative) but with their close spacing, the delayed 3rd dose is necessary to complete training of the cellular system.
Specific antibodies are now easier to assay than 2 years ago but we generally still see "circulating antibodies". These are non-specific and may refer to spike protein or nucleocapsid. The antibodies derived from vaccine-induced immunity tend to be more specific to the Spike, and somewhat more generic even there, while those derived from naturally acquired immunity tend to be more specific for the variant contracted. With the ancestral variants pre-Omicron, this naturally derived immunity tended to be sufficient as the spike and capsid antigens were sufficiently similar to allow activation but omicron, with its massive changes, tended to change the game both in being detected and neutralized and in producing an immune response able to convey to ancestral strains.
Wandering off into the benefits of breastfeeding is well beyond my usual scope (my wife's the boarded IBCLC) and Ob/Gyn was never an area of interest for me. However, the potential holy grail for beating a SARS-CoV-2 infection may be mucosal antibody immune development. Colostrum may contribute an IgA component we've not discussed widely that bears followup.
I'm pretty sure the 3rd dose isn't speculative. I think the timing between mRNA dose 1 and 2 was somewhat speculative because they wanted to see a fast spike in about 30-45 days to counter the onslaught of infection.
To answer your question about Abs testing... NO. without specific examination of the response of the cellular immune system, simple Ab testing provides little information on immune response. We've worked on the theory that both vaccination and infection serve to train the cellular immune system but the work so far has been seminal... and limited on just how well that is going with respect to response directly to SARS-CoV-2 and variants and the variant adaptations, as well as how long the cellular response remains effective. Those studies can take years to get sufficient datapoints to answer those questions.
Paul's comments are pretty solid, but I'm not sure I completely agree with him about the relative risk:benefit of boosters with regard to myocarditis.
New testing systems have been in development since about 11 JAN 2020. CDC suppressed development of various PCR and other assays that were not developed at CDC, unfortunately. I'll not opine on that decision but will note it was after the mass exodus of experienced scientists from CDC in the early Redfield era. I've been struggling to keep up with all the information coming out on a daily basis regarding testing, studies, etc.
This research letter suffers from small study size, almost a study design of opportunity, rather than a prospective study. Still, it provides some useful, if fully anticipated information on neutralization of later elements of the omicron lineage. On a recent podcast, one of Mike Osterholm's guests suggested that, due to extensive changes in the the Spike protein, omicron might be considered another sarcovirus rather than derived from the ancestral COVID line. There might be something to that suggestion. The epi curve defining BA.1 suggested immediately there was little innate immunity to omicron, but that the derived immunity from vaccination, especially with supplementation by boosting later, was beneficial. This was evidenced in the declining number of death we've seen over the last several months.
Their referenced study was very small; statistically, it's impossible to assign significance to it when the number of participants, duration, and lack of randomization, while not disastrous was problematical.
Curious on the challenges in speeding up vaccines with updated instructions? Previously (going all the way back to January 2021 which feels like 10 years ago) in your piece "Vaccines are made with mutations in mind" [1] you noted:
>"However, if a random mutation did render a vaccine useless, the mRNA instructions are incredibly easy to change. This is the beauty of this type of vaccine. It’s like editing a Word document; just tweaking the code a little. And, the FDA wouldn’t need Phase I-III trials again. This is because the code isn’t changed enough to concern safety or efficacy. They would just need to see a study with a few dozen people that showed the new code produced satisfactory amounts of antibodies and protection against the mutated virus." <
Can you elaborate on what hasn't made this a reality? It seems we will be getting Omicron specific vaccine nearly a year after it appeared, give or take a few months. Seems plausible by that time we will be on a new greek letter or sub-sub-variant.
The 6-11 cohort never cracked 30% vaccination rates, I suspect we won't cross half that for the <5 group for similar reasons the older group enthusiasm waned.
Omicron-specific vaccines are in the mill but Moderna has elected to do a mini-Phase 3 trial (assuming my sources are correct). I don't know if they are concerned about the misinformation on mRNA vaccines or some info I've heard that they did, indeed, rush the vaccine (not true, as Katelyn's statements are essentially correct re: modifying the effective proteins).
The low efficacy rates reflect the small number of participants and, eg., the very short duration of the trials, and subsequently a limited number of failures to protect/prevent.
Thank you, as always. I appreciate your advice and am ready to sign my son up for Moderna. However, he will be turning 5 before he can receive his second dose. He turns 5 two weeks after we expect the vaccines to become available. Do I get him a dose of the Moderna anyway? In the past, you have suggested vaccinating as soon as possible. But wondering about this. Does he mix vaccines? Or go with the low dose Pfizer, that is a 3 course shot... but what happens when he turns five?
Good news- Moderna is under 6, not under 5- so there is no quandry! My daughter is turning 5 next week and I have been having similar thoughts in my head as well.
This is the snippet that has convinced me to find an under 6 moderna for my daughter who turning 5 next week vs the Pfizer 5-11 shot. If you had a choice between Pfizer 5-11 and Moderna under 6 for a brand new 5 year old, which would you choose?
Thank you as always! Can you confirm that the data around hospitalizations and deaths in children under 5 is from COVID vs with COVID? One of the source links from the PPT goes to a dead link on the CDC website and the one that I was able to access doesn't show how they define that metric so it's not clear. The infection rate of COVID is high so it's not unreasonable to think that people in hospitals are testing positive even if they're asymptomatic and in the hospital for non-COVID related issues.
Please listen for yourself, but the answer is that most kids in the CDC's surveillance system are hospitalized for COVID and almost all under fives are hospitalized for COVID and not with COVID.
Thank you for sharing this! Just watched. For those not in a place where the can watch the takeaway is that they estimate 87% of those numbers are hospitalizations FOR COVID. They also discuss not being able to predict who will have severe disease - 50% of children hospitalized with COVID-19 do not have underlying conditions.
To expand a little on CC's response, there is very little to differentiate "with" vs "for" COVID-19 except in some media reports. COVID-19 is pervasive enough in that it affects so many organ systems, that an incidental finding of COVID usually means there are other issues to address. A child hospitalized "with" COVID is still subject to the adverse effects on the various organ systems and may present with MIS-C and/or PASC.
Thank you so much for this information! Can I ask you about your opinion on Moderna vs. Pfizer for a 18-month old? I definitely see your points about Moderna's advantages. My only worry is that Moderna's dose may be too large for such a small child. Or do you think the benefits outweigh my concern? Put differently, if your girls were 18-months old, would you still pick Moderna for them?
My kids got omicron just after your family did - will you be spacing out the second Moderna dose? I'm sort of thinking their first dose will provide decent (temporary) protection since they had an infection, and perhaps the second dose 6-8 weeks after may provide more durable immunity vs. getting it right at 4 weeks?
Thank you for this post! Is there info on what level of efficacy is reached after just the first Moderna dose? We have relatives itching to interact this summer and I want to get a better idea of the risks during the "in-between" phase of Moderna doses.
I have a newly minted 5 year old who is supposed to get his Pfizer vaccine this weekend. Thoughts on whether to hold off for a few days to get him the little kid moderna instead?
Agree that little kid Pfizer seems less good than little kid moderna. But any extrapolated opinions on big kid Pfizer compared to little kid moderna?
Hi Katelyn, do you suggest mixing moderna and pfizer for the under fives? My son is one and had his first dose of pfizer. I want him to have optimal protection and have heard you can mix and match as long as he gets three doses (I.e. Pfizer, moderna, moderna or pfizer, pfizer, pfizer, or pfizer, moderna, pfizer). Do you recommend this? I’m having trouble finding information about this for kids. The place my son gets vacations offers both moderna and pfizer. I didn’t understand the data comparing the two vaccines and opted for the initial pfizer dose. Thanks!
I have the same question! Do you see if it has been answered anywhere? My son is eligible and started with Pfizer but I'm wondering if it would be better to get a moderna booster?
Not sure if this is the place to write this comment but I am kind of freaking out. Mom of 3 here. Just took my 2.5 year old to get her fist COVID vaccine. And found out after the shot that we accidentally got phizer instead of the moderna shot we so wanted for her. I don’t know why I didn’t double check before he gave her the shot. So so upset and wondering what the best thing to do at this point is.
Can I switch her to Moderna at this point? And still get two moderna vaccines? I’m guessing the answer is no. Should I just stick to getting her the rest of the phizer series? I really wanted her to have better coverage that moderna offers. Her father and brother have a rare genetic blood disorder that may put them at increased risk for severe illness/hospitalization. I am just so upset about this. Any information you can share would be appreciated so much. Thanks in advance!
Thank you so much for this great summary, as always. I can finally vaccinate my 3-yr old. As of my 6 yr-old, should I get her boosted with Moderna if she had Pfizer? (I mixed my booster (Mod-Mod-Pfizer)
I have been vaccinated and boosted. I most enjoy the MRNA technology. I read through each of the data sets and graphs - including higher rates of hospitialization. I have not seen a clean statement of reduced risk, more importantly a projection of reduced risk giving children a vaccine designed to protect against an older version of COVID. The antibody activity is fine, we know the key for adults is now the impact on T and B cells of the immune system. Everyone fails to acknowledge the lack of longitudinal data and for low probability events - they will not show in small clinical trials. The vaccines for children may work great - the data available is limited. This should be made clear up front. We are going to give vaccines for old variants of covid - we dont' give children vaccines for old variants of the flu
As a mom, I whole-heartedly agree with the statement. We don't do flu shots as a family unless there's a reason - such as I have a newborn at home who has a weaker immune system. Why?
1. It's a vaccine that's required every single year (vs 2-3 shots and done / protected for life)
2. The flu virus mutates quick enough that it's a bit of a guessing game with the vaccine what the dominant variant will be in that flu season.
3. The risk is relatively low if my child catches the flu.
I'm vaccinated and boosted against COVID but, with all the new data coming out, it seems like our current vaccines are not a long term strategy. I also think the data that the CDC put out on efficacy over time with the 5-11 year old vaccine proves that we really don't have enough data with lower doses to show it's effective beyond a very short window of time. I'm not convinced that micro-dosing out in the wild isn't as effective or close to as effective as the vaccine, over time, for younger ages - but that approach has limited research funding since there's no one to fund it.
Keep in mind that an important reason to vaccinate against the flu is to reduce spread to those who are more vulnerable (older people, children who are too young to be vaccinated, people with immune disorders, people undergoing cancer treatments, and people with certain organ disorders).
Far too many people die from the flu every year (roughly 30,000-80,000 in the U.S. most years). We could reduce those numbers a lot if more of us who can be vaccinated do so annually.
Yes. In a perfect world where you know the dominant strain for that year and the vaccine is made for that strain this is correct. While I respect peoples decision to get the flu shot, it’s not a herd immunity vaccine and it doesn’t meet my personal threshold in most years. It’s also not a required vaccine so, to some extent, it doesn’t meet the medical communities threshold for required vaccination either.
I had never heard the phrase “not a herd immunity vaccine,” although I understood your meaning. Of course, that’s because the virus mutates so much, so it’s challenging to come up with such a thing.
But in the process I came across this, which notes two relevant things:
(1) a vaccine that works against all mutations of the flu virus, current and future, is in development.
But also (2) the flu vaccines we have now would be more effective if more people got vaccinated, because otherwise we get more mutations.
“It would sure help if more people GOT their flu vaccine though… we only get about half of people covered in the United States each year. And every new case is another chance for the virus to mutate. Really high vaccine coverage could slow down the drift process and make this year’s vaccine last longer.”
— Malia Jones, PhD MPH
https://dearpandemic.org/why-herd-immunity-has-not-been-achieved-in-some-viruses/
Even in a not perfect world, it will slow spread if it’s at all effective. Slowing spread a little can add up to big numbers, as we all have seen recently.
Yes, your choice, of course. But there’s a reason public health scientists recommend them: to save lives.
And also, of course, to reduce unnecessary suffering and long-term effects for those who catch and survive the flu. It’s not nothing.
I thought the flu was no big deal until I caught it 10 years ago. Turns out I was thinking of what people call the “stomach flu,” which isn’t a flu at all. The actual flu was a miserable experience I would rather not go through again, at a healthy, fit 44 years old. I’d never want to put a kid through that, or an elderly person.
Glad you healed from that, it sounds like it was a harsh experience.
"...but data will be closely followed".
Having closely followed the roll out here in Australia, I don't feel reassured by your words. Here's a short clip of a very nervous Queensland Chief Health Officer Dr John Gerrard telling us they're "keeping a close eye" on reports of people dying suddenly from myocarditis after a short illness: https://rumble.com/vwhgw9-australian-health-official-vaxed-are-dying-from-myocarditis.html
Note how he corrects himself from "a few" reports to "reports". Months before this press conference, it was reported in our media that two Australian journalists were hospitalised for myocarditis following pfizer (Georgia Clark and Denham Hitchock). Denham Hitchock's case certainly wasn't mild and we don't know if there's permanent scarring that could increase his risk of chronic heart failure in the future.
Here's Queensland Minister of Health and Ambulance Services Yvette D'Ath reporting on a 40% rise in call outs for cardiac arrests, chest pains and respiratory issues:https://rumble.com/v10uifl-queensland-health-minister-cant-explain-sudden-40-heart-attacks-chest-pains.html
A couple of reporters shout out, asking if it's the vaccines but D'Ath dismisses them, saying "Vaccines actually help people stay out of hospital".
Here are testimonials from ICU nurses (general and cardiac) at a Health and Welfare Meeting of the Louisiana House of Reps about the "terrifying" injuries they're seeing from these shots. The nurses all say the injuries are not being reported to VAERS. They speak at the one hour mark: https://house.louisiana.gov/H_Video/VideoArchivePlayer?v=house/2021/nov/1108_21_HW
In this climate of fierce censorship, you'll get a better idea of what's going on by physically going to places yourself or ringing people up and speaking to them directly. You can contact Monte Vista school in CAL; they have 4 cases of myocarditis following the shots in approx 800 students (presumably 50% boys.)
The rate at Monte Vista fits what I've seen in this city of Melbourne, Australia. I don't know that many people but I know two young men (aged 20) who are friends who both got myocarditis after pfizer. They're being seen by the same cardiologist. Neither case is mild. Their prognosis is unknown.
Despite the censorship, you can still find studies that report a higher incidence of myocarditis from the Covid shots. When the study by Patone et al. was redone according to age and gender, investigators found a higher rate of myocarditis in jab recipients skewed to younger males.
As for heart inflammation from the mRNA shots being mild and rare, Ernest Ramirez's son Ernesto aged 16 died after pfizer. Mr. Ramirez didn't know there was any risk of death. He was offered money to keep quiet but refused. There are other cases such as that of Sean Hartman.
Published studies have found permanent damage to hearts following the mRNA shots in the form of fibrosis (Bozkurt et al) and necrosis (Matta et al.), so it's reasonable to think that in some cases extensive damage could lead to death.
You recommend Moderna over Pfizer. We know males of younger age are more at risk of heart inflammation from the mRNA shots and there's a higher risk with Moderna (Sweden, Norway and Finland halted Moderna in under 30s). I therefore don't understand your logic that myocarditis could be less common in the youngest age group, particularly when you're advocating Moderna.
We know the trials in adults were under powered to detect myocarditis but that it still occurred in the real world. There are over 1000 peer-reviewed papers on other adverse effects from the Covid shots, such as transverse myelitis that appeared on FDA slides in December 2020 and is listed in pfizer's postmarketing experience document.
There are websites where you can listen to and read testimonials from people who have been injured by these shots: https://www.realnotrare.com/ https://www.nomoresilence.info/ https://www.jabinjuriesglobal.com/ and a physician led one: https://react19.org/
Even without extensive real world data on injuries, there were major red flags in the original RCTs:
Compare the NEJM report with the FDA one on the Pfizer trial for ages 12-15. Do you know the reasons for the discrepancy in numbers of children who didn't receive a second dose? Do you know the reasons why these children didn't get a second dose?
Brianne Dressen's severe neurological AE was censored from the AZ trial because it occurred after one dose. There's every reason to suspect that could have gone on in the Pfizer trial. Moreover, both Brianne and Stephanie de Garay (whose daughter Maddie was paralysed on the pfizer trial) say trial participants could only report AEs by choosing from a pre-specified list of minor ones.
I question the reliability of any source that makes statements I consider disingenuous. You said Pfizer reporting scalding from coffee (nothing to do with their drug) was an example of rigour. You neglect to mention they passed off a case of paralysis in a child aged twelve as a stomach ache in their published report. It's blatant fraud and criminally negligent not to investigate such a severe case before rolling out to healthy children.
You're strongly urging parents to give their babies and toddlers what the FDA in 2020 considered to be experimental (the EUA document calls the Covid vaccines "investigational") gene therapy (Moderna's SEC filing document from April 2020 states the FDA considered mRNA to be gene therapy.)
If a product is marketed as a vaccine, then certain safety studies don't need to be done; studies in carcinogenicity and genotoxicity were not done because the drug was not "expected' to have an adverse effect in this regard, as you can see on page 29 of Pfizer's document:https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_24_nonclinical-overview.pdf
Clinical trials to determine safety in reproductive health are ongoing. You may be aware that menstrual irregularities have been reported globally, including in the BMJ. There are two reports of vaginal haemorrhaging in a woman and a child aged 11 on the TGA DAEN website. The child appears on page 35. Note the rat bleeding on the vulva that was euthanized (page 55) in the pfizer study:
https://www.tga.gov.au/sites/default/files/foi-2389-06.pdf
Note also how much of this animal study in safety is redacted. As a parent, does any of this concern you?
The covid inoculations don't reduce transmission at all. The only reason to give these mRNA drugs to children would be to reduce their risk of a severe outcome. Where's the evidence, even in the original clinical trials in adults for the original variant, that they reduce the risk of a severe outcome?
These drugs are, at best, a symptom mitigator with a limited window of efficacy.
I'm happy for all those families with little ones who have waited so long. Congratulations :)
Vaccination, even against the original coronavirus, seems to be holding up as our best option against new variants, long Covid, reinfection, and longer term bad stuff that gets discussed by thought leaders on sites like twitter.
I will definitely be recommending vaccination with the existing mRNA vaccines for this age group as an imperfect, better-late-than-never imperative. Thanks for the unofficial tilt towards Moderna over Pfizer in the <5 yo's.
Anticipating a bivalent (including Omicron) booster in the fall for adults and kids most likely, and I'm tilting towards mixing and matching boosters.
A good week for Moderna and kids <17:
https://www.medscape.com/viewarticle/975594#vp_1
I'm not sure we'll see the efficacy of an omicron-included booster (but I hope I'm wrong). I'm holding out for a pan-sarbovirus vaccine within a couple of years, though. Agree with your comments overall. I'll be recommending vaccination for the kids, and I've already started preferring a mix'n'match approach on the third (completion) done and booster.
First things first: I suspect the immunity derived from breastfeeding has an IgA component. Thus, a better mucosal response for those who got a load of antibodies that way. Studies looking, in vitro, at IgA effect on on SARS-CoV-2 noted that mucosal response was more likely to reduce viral load and prevent at least symptomatic disease.
I've been in the Hotez camp for a long time: If the first 2 doses of mRNA vaccines had been 10-12 weeks apart, the 3rd dose might not be necessary (but that remains speculative) but with their close spacing, the delayed 3rd dose is necessary to complete training of the cellular system.
Specific antibodies are now easier to assay than 2 years ago but we generally still see "circulating antibodies". These are non-specific and may refer to spike protein or nucleocapsid. The antibodies derived from vaccine-induced immunity tend to be more specific to the Spike, and somewhat more generic even there, while those derived from naturally acquired immunity tend to be more specific for the variant contracted. With the ancestral variants pre-Omicron, this naturally derived immunity tended to be sufficient as the spike and capsid antigens were sufficiently similar to allow activation but omicron, with its massive changes, tended to change the game both in being detected and neutralized and in producing an immune response able to convey to ancestral strains.
Wandering off into the benefits of breastfeeding is well beyond my usual scope (my wife's the boarded IBCLC) and Ob/Gyn was never an area of interest for me. However, the potential holy grail for beating a SARS-CoV-2 infection may be mucosal antibody immune development. Colostrum may contribute an IgA component we've not discussed widely that bears followup.
I'm pretty sure the 3rd dose isn't speculative. I think the timing between mRNA dose 1 and 2 was somewhat speculative because they wanted to see a fast spike in about 30-45 days to counter the onslaught of infection.
To answer your question about Abs testing... NO. without specific examination of the response of the cellular immune system, simple Ab testing provides little information on immune response. We've worked on the theory that both vaccination and infection serve to train the cellular immune system but the work so far has been seminal... and limited on just how well that is going with respect to response directly to SARS-CoV-2 and variants and the variant adaptations, as well as how long the cellular response remains effective. Those studies can take years to get sufficient datapoints to answer those questions.
Paul's comments are pretty solid, but I'm not sure I completely agree with him about the relative risk:benefit of boosters with regard to myocarditis.
New testing systems have been in development since about 11 JAN 2020. CDC suppressed development of various PCR and other assays that were not developed at CDC, unfortunately. I'll not opine on that decision but will note it was after the mass exodus of experienced scientists from CDC in the early Redfield era. I've been struggling to keep up with all the information coming out on a daily basis regarding testing, studies, etc.
This research letter suffers from small study size, almost a study design of opportunity, rather than a prospective study. Still, it provides some useful, if fully anticipated information on neutralization of later elements of the omicron lineage. On a recent podcast, one of Mike Osterholm's guests suggested that, due to extensive changes in the the Spike protein, omicron might be considered another sarcovirus rather than derived from the ancestral COVID line. There might be something to that suggestion. The epi curve defining BA.1 suggested immediately there was little innate immunity to omicron, but that the derived immunity from vaccination, especially with supplementation by boosting later, was beneficial. This was evidenced in the declining number of death we've seen over the last several months.
Their referenced study was very small; statistically, it's impossible to assign significance to it when the number of participants, duration, and lack of randomization, while not disastrous was problematical.
Katelyn -
Curious on the challenges in speeding up vaccines with updated instructions? Previously (going all the way back to January 2021 which feels like 10 years ago) in your piece "Vaccines are made with mutations in mind" [1] you noted:
>"However, if a random mutation did render a vaccine useless, the mRNA instructions are incredibly easy to change. This is the beauty of this type of vaccine. It’s like editing a Word document; just tweaking the code a little. And, the FDA wouldn’t need Phase I-III trials again. This is because the code isn’t changed enough to concern safety or efficacy. They would just need to see a study with a few dozen people that showed the new code produced satisfactory amounts of antibodies and protection against the mutated virus." <
Can you elaborate on what hasn't made this a reality? It seems we will be getting Omicron specific vaccine nearly a year after it appeared, give or take a few months. Seems plausible by that time we will be on a new greek letter or sub-sub-variant.
The 6-11 cohort never cracked 30% vaccination rates, I suspect we won't cross half that for the <5 group for similar reasons the older group enthusiasm waned.
[1] https://yourlocalepidemiologist.substack.com/p/vaccines-are-made-with-mutations-in-mind?s=r
Omicron-specific vaccines are in the mill but Moderna has elected to do a mini-Phase 3 trial (assuming my sources are correct). I don't know if they are concerned about the misinformation on mRNA vaccines or some info I've heard that they did, indeed, rush the vaccine (not true, as Katelyn's statements are essentially correct re: modifying the effective proteins).
The low efficacy rates reflect the small number of participants and, eg., the very short duration of the trials, and subsequently a limited number of failures to protect/prevent.
Thank you, as always. I appreciate your advice and am ready to sign my son up for Moderna. However, he will be turning 5 before he can receive his second dose. He turns 5 two weeks after we expect the vaccines to become available. Do I get him a dose of the Moderna anyway? In the past, you have suggested vaccinating as soon as possible. But wondering about this. Does he mix vaccines? Or go with the low dose Pfizer, that is a 3 course shot... but what happens when he turns five?
Thanks for any advice.
Good news- Moderna is under 6, not under 5- so there is no quandry! My daughter is turning 5 next week and I have been having similar thoughts in my head as well.
I am struggling to find evidence to support this snippet:
> By the end of summer, Moderna kids will likely be on the same playing field as adults, who will likely get a bivalent vaccine this fall.
It sounds as if Moderna is testing a bivalent booster, but for adults. How will that be rolled out to the under 5s? Why are you confident it will be?
This is the snippet that has convinced me to find an under 6 moderna for my daughter who turning 5 next week vs the Pfizer 5-11 shot. If you had a choice between Pfizer 5-11 and Moderna under 6 for a brand new 5 year old, which would you choose?
Thank you as always! Can you confirm that the data around hospitalizations and deaths in children under 5 is from COVID vs with COVID? One of the source links from the PPT goes to a dead link on the CDC website and the one that I was able to access doesn't show how they define that metric so it's not clear. The infection rate of COVID is high so it's not unreasonable to think that people in hospitals are testing positive even if they're asymptomatic and in the hospital for non-COVID related issues.
This specific question was asked and answered in the June 14 VRBPAC:
https://www.youtube.com/watch?v=GbNpaZeDPiA&t=5683s
Please listen for yourself, but the answer is that most kids in the CDC's surveillance system are hospitalized for COVID and almost all under fives are hospitalized for COVID and not with COVID.
Thank you for sharing this! Just watched. For those not in a place where the can watch the takeaway is that they estimate 87% of those numbers are hospitalizations FOR COVID. They also discuss not being able to predict who will have severe disease - 50% of children hospitalized with COVID-19 do not have underlying conditions.
To expand a little on CC's response, there is very little to differentiate "with" vs "for" COVID-19 except in some media reports. COVID-19 is pervasive enough in that it affects so many organ systems, that an incidental finding of COVID usually means there are other issues to address. A child hospitalized "with" COVID is still subject to the adverse effects on the various organ systems and may present with MIS-C and/or PASC.
Thank you so much for this information! Can I ask you about your opinion on Moderna vs. Pfizer for a 18-month old? I definitely see your points about Moderna's advantages. My only worry is that Moderna's dose may be too large for such a small child. Or do you think the benefits outweigh my concern? Put differently, if your girls were 18-months old, would you still pick Moderna for them?
Anecdote— my 15 month old had his first moderna last week and no issues 🙂
I don't think the dose is overdone for the smaller munchkins, In fact, it's a very modest dose and the safety data are pretty good from the trial.
My kids got omicron just after your family did - will you be spacing out the second Moderna dose? I'm sort of thinking their first dose will provide decent (temporary) protection since they had an infection, and perhaps the second dose 6-8 weeks after may provide more durable immunity vs. getting it right at 4 weeks?
Thank you for this post! Is there info on what level of efficacy is reached after just the first Moderna dose? We have relatives itching to interact this summer and I want to get a better idea of the risks during the "in-between" phase of Moderna doses.
We have the same question- just posted :)
Thank you for this!
I have a newly minted 5 year old who is supposed to get his Pfizer vaccine this weekend. Thoughts on whether to hold off for a few days to get him the little kid moderna instead?
Agree that little kid Pfizer seems less good than little kid moderna. But any extrapolated opinions on big kid Pfizer compared to little kid moderna?
Thank you again. You are a gifted communicator.
Hi Katelyn, do you suggest mixing moderna and pfizer for the under fives? My son is one and had his first dose of pfizer. I want him to have optimal protection and have heard you can mix and match as long as he gets three doses (I.e. Pfizer, moderna, moderna or pfizer, pfizer, pfizer, or pfizer, moderna, pfizer). Do you recommend this? I’m having trouble finding information about this for kids. The place my son gets vacations offers both moderna and pfizer. I didn’t understand the data comparing the two vaccines and opted for the initial pfizer dose. Thanks!
I have the same question! Do you see if it has been answered anywhere? My son is eligible and started with Pfizer but I'm wondering if it would be better to get a moderna booster?
Not sure if this is the place to write this comment but I am kind of freaking out. Mom of 3 here. Just took my 2.5 year old to get her fist COVID vaccine. And found out after the shot that we accidentally got phizer instead of the moderna shot we so wanted for her. I don’t know why I didn’t double check before he gave her the shot. So so upset and wondering what the best thing to do at this point is.
Can I switch her to Moderna at this point? And still get two moderna vaccines? I’m guessing the answer is no. Should I just stick to getting her the rest of the phizer series? I really wanted her to have better coverage that moderna offers. Her father and brother have a rare genetic blood disorder that may put them at increased risk for severe illness/hospitalization. I am just so upset about this. Any information you can share would be appreciated so much. Thanks in advance!
Have you found any info about this? We are in the same boat!
Thank you so much for this great summary, as always. I can finally vaccinate my 3-yr old. As of my 6 yr-old, should I get her boosted with Moderna if she had Pfizer? (I mixed my booster (Mod-Mod-Pfizer)
Thank you! I think my 3 year old granddaughter will be getting Moderna also. Finally!